Background
Methods/Design
Design of the study
Setting
Participants
Power calculation
Randomization method
Enrolment procedure
Health care institutions
National fibromyalgia and chronic fatigue patient association
Interventions
Control group
Intervention group
4-STEPS sessions | Topics |
---|---|
Motivational Interviewing- Session 1
| ✓ Listen to patient complaints, with emphasis on fatigue. |
✓ Illness perceptions. | |
✓ Exploration of patients' present physical activity behavior. | |
✓ Current health behaviors and other activities are explored (physical activity, sleep, pain, etc.). | |
✓ Discussion of the information on the booklet given previously (specially the relation between CF major symptoms and physical activity behavior and boom-bust pattern). | |
✓ Motivation and Confidence Scales: Exploration of the willingness to engage in physical activity (or adjust current physical activity behavior) and the confidence in one's own capability to achieve this behavior with success. | |
✓ Discussion of the pros and cons (not-) to change physical activity behavior (Decisional Balance). | |
✓ Social support network is addressed. | |
Motivational Interviewing- Session 2
| ✓ Exploration of possible competing goals with physical activity (e.g. housework chores) and link to core values. |
✓ Strategies to overcome obstacles to physical activity and competing goals are addressed. | |
✓ Based on the register of daily activities and steps taken (pedometer register) and GET scheme for physical activity, the patient establishes a personal physical activity goal for the following two months. | |
✓ Discuss the possible reasons for perpetuation of symptoms and difficulty to change health behaviors in CF patients, namely perfectionism, fear of movement, presence of stressful situations and boom-bust pattern. (some are already mentioned at the first motivational interview and are now emphasized). | |
✓ Exploration of emotion control importance and techniques (e.g. relaxation techniques). | |
Telephone sessions:
| ✓ Revision of the physical activity goal planning (adequacy to the patients' present situation). |
✓ Relapse prevention (strategies to overcome new or persisting difficulties to physical activity and emotion control strategies). |
4-STEPS materials | TOPICS |
---|---|
Self-regulation Informational booklet
| ✓ Overview of Chronic Fatigue: CDC diagnosis criteria, epidemiology information, etiology, possible factors that contribute to a better or words prognosis (e.g. physical inactivity/activity). |
✓ Physical activity: current physical activity guidelines for adults in general population, physical and psychological benefits of physical activity, benefits of physical activity for CF. Information about different types of physical activities (that are appropriated for CF) such as walking as well the importance and illustration of relaxation training. | |
✓ Link between CF symptoms and physical (in-) activity (deconditioning cycle) and boom-bust pattern (erratic pattern of rest and activity). | |
Self-regulation Workbook
|
STEP 1 - "Am I ready to start?"
|
✓ Motivation and Confidence Scales: Patients' willingness and confidence to do adjusted levels of physical activity is assessed on a scale for ranging from 0% (not at all) to 100% (very much). | |
✓ Decisional Balance: list of the pros and cons (not-) to change in relation to physical activity. | |
✓ Competing goals with exercise: information on the importance o analyzing possible competing goals (or conflicting activities) with exercise that may be refraining patients from physical activity. List of two main activities (e.g. other leisure activities). | |
✓ Activity/Rest Diary and Pedometer log - instructions to use for two weeks (interval between MI sessions) and the importance of the pedometer as a motivational strategy. | |
STEP 2 - "My physical activity goal":
| |
✓ GET Scheme and daily activity management: information on the importance of increase physical activity level gradually, consider the way patients feel in different days (different levels if patients is feeling good or bad), importance of rest during physical activity, importance of adjusting physical activity levels to the amount of effort spent in that day (balance between activities and rest). | |
✓ Goal setting activity: explanation of how to set a goal (SMART - specific, measurable, achievable, realistic and timely), formulation of a personal physical activity goal to achieve in 2 months time (e.g. to do brisk walking four days per week for 30 minutes (plus 10 minutes break), implementation intentions (type of activity, frequency and intensity, period of the day, with whom, where) and a goal ladder (patients formulate goals for every 2 weeks until reaching the two months time and main goal. | |
✓ Information on self-rewarding for each step goal achieved. | |
✓ Tips for managing daily activities and incorporate physical activity on the daily routine | |
STEP3 - "Overcoming obstacles":
| |
✓ Problem solving activity: List two main physical activity barriers and a strategy to overcome it. | |
STEP 4 - "I am physically active...and I want to keep that way":
| |
✓ Relapse prevention information and strategies | |
Resources and support for CF and physical activity. | |
Pedometer Record
| ✓ Similar to the record used for the assessment (day of the week and number of steps for each day). |
Daily activities record
| ✓ Record containing the days of the week and hours each day. Patients fill the activities they do in each hour of day. The options are: physical activities, other activities (activities requiring mental effort) and rest. Each option is explained in detail. |
Leaflet for family
| ✓ Facts about CF. |
✓ Brief information on the relation between physical activity and CF. | |
✓ Tips for partners or other relatives to support patients with CF. |
Assessments
Baseline | Post-test | 12 months | |
---|---|---|---|
Demographics | X | ||
Severe infection | X | ||
Life event | X | ||
Medical advice | X | ||
Duration Symptoms and diagnosis | X | ||
CFS symptom checklist | X | X | X |
Presence of FM symptoms | X | X | X |
CIS-20R | X | X | X |
Impact of fatigue | X | X | X |
NFR | X | X | X |
Work related questions | X | X | X |
Brief IPQ-R | X | X | X |
Brief IPQ-R causes subscale | X | ||
CERQ positive subscales | X | X | X |
PCS | X | X | X |
BRIQ | X | X | X |
Social support | X | X | X |
BSI | X | X | X |
Sleep | X | X | X |
PHQ-15 | X | X | X |
SF-12 | X | X | X |
Physical Activity history | X | X | X |
Steps taken (pedometer) | X | X | X |
Physical activity intention | X | ||
Action planning | X | ||
Coping planning | X | ||
SRSB Physical activity goal elicitation | X | ||
SRSB Physical activity goal progress | X | X | X |
SRSB goal efficacy scale | X | ||
SRSB all scales | X | X | |
Barriers Efficacy | X | X | X |
TSRQ | X | X | X |
Intervention evaluation (intervention condition) | X |